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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08979 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1267 | Other Identifier | M D Anderson Cancer Center |
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This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.
PRIMARY OBJECTIVE:
I. To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram [FFDM] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast.
SECONDARY OBJECTIVES:
I. To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast.
II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth.
III. To evaluate the incremental cancer detection rate provided by CEM, DBT, and ultrasound (US) compared to the outside facility (OSF) diagnosis.
EXPLORATORY OBJECTIVES:
I. To evaluate the rate of referral to breast magnetic resonance imaging (MRI) in the study cohort.
II. To evaluate the performance of MRI for breast cancer diagnosis and compare it with other imaging modalities of CEM, LE images, DBT, and US.
III. To evaluate the feasibility of CEM-guided biopsy of CEM-only detected lesions.
OUTLINE:
Patient receive iodinated contrast agent intravenously (IV) and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
After completion of study treatment, patients are followed up for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CEM, DBT, medical record) | Experimental | Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-Enhanced Mammography | Procedure | Undergo CEM |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts. | Rate of malignancy in lesions de-novo detected on CEM at MDACC and not detected on outside facility imaging. New non-index lesions detected on CEM that had a benign/malignant outcome on image-guided biopsy, surgery, or had a 24-month imaging follow-up with no cancer development (lesion-level evaluation) *Index lesion was defined as follows: A) Known cancer detected at an outside facility B) Highly suspicious imaging lesion detected at an outside facility, for which a consultation was requested | One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth. | Fraction of malignant lesions detected by each component of CEM | At presentation, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Breast MRI Utilization and the Corresponding Diagnosis in the Study Cohort. | Percentage of patients who underwent both CEM and MRI | One timepoint for CEM data (at presentation) +/- 2 month (4 month total) for MRI |
| The Fraction of CEM Biopsies That Achieve Adequate Sampling of the Target. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olena Weaver | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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Eligible and interested subjects will be consented for study participation. A research staff member who is trained in the informed consent process will explain the study, invite the patients to enroll, and obtain the informed consent of women who wish to participate. Subjects may be enrolled using the approved MD Anderson procedures for remote consenting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion |
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2021 |
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| Digital Tomosynthesis Mammography | Procedure | Undergo DBT |
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| Electronic Health Record Review | Other | Medical records reviewed |
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| Iodinated Contrast Agent | Drug | Given IV |
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| Percentage of Lesions That Appeared Larger on CEM |
Largest measurements in imaging were compared to the largest measurements in pathology and the size difference of 5mm or more was considered significant. Fraction of patients in whom CEM detected an increase in lesion size of 5 mm or more was reported and analyzed. |
| One timepoint- at presentation |
| Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging | Percentage of patients with a change in the number of cancers sites (unifocal, multifocal, or bilateral) compared to outside facility imaging interpretation | 1 timepoint at presentation |
| Rate of Malignancy | Rate of RC-only detected malignancy, LE+RC detected malignancy, LE-only detected malignancy | One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection |
Patients who required a CEM-guided biopsy and successfully underwent it with adequate tissue sampling. Percentage of all non-index CEM lesions that required a CEM biopsy. |
| Two timepoints- at first CEM imaging presentation and at CEM-guided biopsy (within 2 months) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion |
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| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts. | Rate of malignancy in lesions de-novo detected on CEM at MDACC and not detected on outside facility imaging. New non-index lesions detected on CEM that had a benign/malignant outcome on image-guided biopsy, surgery, or had a 24-month imaging follow-up with no cancer development (lesion-level evaluation) *Index lesion was defined as follows: A) Known cancer detected at an outside facility B) Highly suspicious imaging lesion detected at an outside facility, for which a consultation was requested | Posted | Number | % of malignancy in new CEM lesions | One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection | Total number of lesions | Total number of lesions |
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| Secondary | Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth. | Fraction of malignant lesions detected by each component of CEM | Posted | Number | lesions | At presentation, Day 1 | Total number of lesions | Total number of lesions |
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| Secondary | Percentage of Lesions That Appeared Larger on CEM | Largest measurements in imaging were compared to the largest measurements in pathology and the size difference of 5mm or more was considered significant. Fraction of patients in whom CEM detected an increase in lesion size of 5 mm or more was reported and analyzed. | Posted | Number | % of malignant lesions larger on CEM | One timepoint- at presentation | Total number of lesions | Total number of lesions |
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| Secondary | Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging | Percentage of patients with a change in the number of cancers sites (unifocal, multifocal, or bilateral) compared to outside facility imaging interpretation | Patients who had additional malignant lesions detected as a result of CEM work-up | Posted | Count of Participants | Participants | 1 timepoint at presentation |
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| Secondary | Rate of Malignancy | Rate of RC-only detected malignancy, LE+RC detected malignancy, LE-only detected malignancy | Posted | Number | percentage of malignancy | One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection | Total number of lesions | Total number of lesions |
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| Other Pre-specified | Rate of Breast MRI Utilization and the Corresponding Diagnosis in the Study Cohort. | Percentage of patients who underwent both CEM and MRI | Study patients who underwent both breast MRI and CEM. The fraction of the patients with MRI prompting a change in management | Posted | Count of Participants | Participants | One timepoint for CEM data (at presentation) +/- 2 month (4 month total) for MRI |
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| Other Pre-specified | The Fraction of CEM Biopsies That Achieve Adequate Sampling of the Target. | Patients who required a CEM-guided biopsy and successfully underwent it with adequate tissue sampling. Percentage of all non-index CEM lesions that required a CEM biopsy. | Posted | Number | percentage of successful CEM biopsies | Two timepoints- at first CEM imaging presentation and at CEM-guided biopsy (within 2 months) | Lesions | Lesions |
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At presentation, Day 1
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion |
| 0 | 89 | 0 | 89 | 2 | 89 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Saline flush extravasation | General disorders | Systematic Assessment |
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| Mild nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olena Weaver | M.D. Anderson Cancer Center | 713-471-3613 | ooweaver@mdanderson.org |
| Feb 6, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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